长沙招聘

职位描述：
1、能够查阅、翻译中英文文献资料，进行项目的前期调研并形成调研报告，根据要求制定研发方案；
 Have the ability of consult and translate both Chinese and English literature,
Conduct the investigation and research report in the early stages of the project, Draft research and development program according to the requirement for research and development plan;
2按照中国法规要求，设计并进行原辅料相容性研究试验；
According to the regulations in China, design and carry out API and excipient compatibility studies;
3 进行生产工艺的研发和优化；
Go on development and optimization of production process;
4 新生产工艺的放大及技术转移；
The new production process of technology transfer and scale up ;
5讨论并解决新产品研发过程中出现的相关问题；
Discuss and solve related problems appeared in the process of new product development;
6 负责仪器设备日常维护，实验室日常管理；
Responsible for the routine maintenance of instruments and equipment, laboratory daily management;
7 负责药品研究资料、原始记录和各种报告的整理，完成处方工艺开发报告；
Responsible for drug research materials, original records, and all kinds of report, complete the prescription craft development report;
8 技术指导制剂验证生产，并完成生产总结报告；
Technical guidance to verify production, and completes the production summary report;
9、 工艺改进和关键工艺的实施布置，参与新技术、新工艺的开发和实施。
Process improvement and implementation of the key technology to decorate, participate in the development of new technology, new process and implementation.
10 按CTD格式和要求撰写注册资料；
According to the requirements of CTD format and write the registration data;
11 熟悉新药研发申报和仿制药质量和疗效一致性评价的法规和指导原则；
Be familiar with the new drug research and development to declare consistency and quality of generic drugs and curative effect evaluation of regulations and guidelines;
12 能够按时保质保量的完成部门及公司领导临时安排的其他任务。
To ensure the quality of on time to complete other tasks assigned by the department or
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昆山龙灯瑞迪制药有限公司是由加拿大龙灯集团与印度瑞迪博士制药有限公司及昆山双鹤制药有限公司三方合资的一高新技术制药企业，公司主要生产经营医药原料及制剂产品。“引导健康新生活”是公司的核心目标，我们立志为人类健康事业做出应有的贡献。公司诚邀各界有识之士加盟“龙灯瑞迪”，共同创造美好未来。